FDA.reportPublic FDA data

ARVIS ®

Primary DI
00810180350341
Brand
ARVIS ®
Company
KICO KNEE INNOVATION COMPANY PTY LIMITED
Model
IN-20400
Device description
Tibial Reference Mount, Right
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810180350341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810180350341008101803503418101803503410810180350341

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
757918953
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810180350020ARVIS ®IN-280002025-11-17
00810180350037ARVIS ®IN-280102025-11-17
00810180350044ARVIS ®IN-280202025-11-17
00810180350051ARVIS ®IN-280502025-11-17
00810180350068ARVIS ®IN-280702025-11-17
00810180350099ARVIS ®IN-281002025-11-17
00810180350105ARVIS ®IN-281202025-11-17
00810180350112ARVIS ®IN-281302025-11-17
00810180350167ARVIS ®IN-281502025-11-17
00810180350174ARVIS ®IN-281602025-11-17
00810180350785ARVIS ®IN-290002025-11-17
00810180350792ARVIS ®IN-291002025-11-17
00810180350808ARVIS ®IN-290022025-11-17
00810180350815ARVIS ®IN-290052025-11-17
00810180350822ARVIS ®IN-290032025-11-17
00810180350839ARVIS ®IN-290072025-11-17
00810180350846ARVIS ®IN-290082025-11-17
00810180350853ARVIS ®IN-290182025-11-17
00810180350860ARVIS ®IN-290302025-11-17
00810180350877ARVIS ®IN-290012025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810131882457Ion Navigation Drill Bit - 5.5mmSurgentec, LLCOLO2026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSurgentec, LLCOLO2026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSurgentec, LLCOLO2026-07-06
00810131882556TiLink-L Navigation Drill GuideSurgentec, LLCOLO2026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSurgentec, LLCOLO2026-07-06
00810131882617TiLink-L Navigation Impact CapSurgentec, LLCOLO2026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSurgentec, LLCOLO2026-07-06
00810131883669Ion Navigation Inserter AOSurgentec, LLCOLO2026-07-06
00810131884871ION-C Navigation Reusable TraySurgentec, LLCOLO2026-07-06
00810131884970ION-C Navigation Reusable Tray AssemblySurgentec, LLCOLO2026-07-06
10705034647845TRIALTISMedos International SàrlOLO2026-07-04
10705034647852TRIALTISMedos International SàrlOLO2026-07-04
10705034647883TRIALTISMedos International SàrlOLO2026-07-04
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00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08